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Federal Register / Vol. 86, No. 13 / Friday, January 22, 2021 / Proposed Rules commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for the denial in the Federal Register. A petitioner may commence a civil action in a U.S.
district court seeking to compel initiation of the requested proceeding within 60 days of a denial or, if EPA
does not issue a decision, within 60
days of the expiration of the 90-day period.
C. What criteria apply to a decision on a TSCA section 21 petition?
1. Legal Standard Regarding TSCA
Section 21 Petitions TSCA section 21b1 requires that the petition set forth the facts which it is claimed establish that it is necessary to initiate the proceeding requested. 15
U.S.C. 2620b1. Thus, TSCA section 21 implicitly incorporates the statutory standards that apply to the requested actions. Accordingly, EPA has relied on the standards in TSCA section 21 and in the provisions under which actions have been requested in evaluating this TSCA section 21 petition.
2. Legal Standard Regarding TSCA
Section 4a1Ai
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EPA must make several findings in order to require testing under TSCA
section 4a1Ai through a rule or order. EPA must find that the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment; that information and experience are insufficient to reasonably determine or predict the effects of a chemical substance on health or the environment;
and that testing of the chemical substance is necessary to develop the missing information. Further, TSCA
section 4h requires EPA to reduce and replace the use of vertebrate animals in the testing of chemical substances or mixtures, to the extent practicable, scientifically justified, and consistent with the policies of TSCA.

26i requires that decisions under TSCA sections 4, 5, and 6 be based on the weight of scientific evidence.
TSCA section 26k requires that EPA
consider information that is reasonably available in carrying out TSCA sections 4, 5, and 6.
II. Summary of the TSCA Section 21
Petition A. What action was requested?
On October 14, 2020, Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance petitioners petitioned EPA to initiate a rulemaking proceeding or issue an order under TSCA section 4a1Ai, compelling health and environmental effects testing, including studies of communities exposed to PFAS-contaminated drinking water, on 54 PFAS that the petitioners assert are manufactured by The Chemours Company Chemours at its chemical production facility in Fayetteville, North Carolina. The petitioners also request that EPA ask the National Academy of Sciences to create an independent science panel to oversee all aspects of the testing program requested by the petitioners Ref. 1.

3. Legal Standard Regarding TSCA
Section 26

B. What support did the petitioners offer?
The petitioners assert that TSCA
section 4a1Ai requires EPA to direct testing on a chemical substance or mixture if all three of the following findings are made:
The manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment;
There is insufficient information and experience upon which the effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted; and Testing of such substance or mixture with respect to such effects is necessary to develop such information.

TSCA section 26h requires EPA, in carrying out TSCA sections 4, 5, and 6, to make a decision using scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, while also taking into account six considerations, including the relevance of information and any uncertainties. TSCA section
1. May Present an Unreasonable Risk of Injury to Health or the Environment The petitioners assert that the 54
PFAS may present an unreasonable risk of injury to health or the environment because there allegedly is substantial evidence that PFAS may be toxic, pointing to the following documents:
The Agency for Toxic Substances and Disease Registrys ATSDRs draft
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2018 Toxicological Profile for Perfluoroalkyls Ref. 2 and EPAs PFAS
Action Plan Ref. 3, as well as other literature, in support of the contention that exposure to certain, specific PFAS
are associated with adverse health effects.
EPAs Significant New Use Rule SNUR for Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances Ref. 4, which states while most studies to date have focused primarily on PFOS, structure-activity relationship analysis indicates that the results of those studies are applicable to the entire category of PFAS, which includes PFOS. Available test data have raised concerns about their potential developmental, reproductive, and systemic toxicity.
EPAs Consent Order regarding DuPont Premanufacture Notices Ref. 5, which states in part toxicity studies on the analogs PFOA perfluorooctanoic acid and PFOS
perfluorooctanesulfonic acid indicate developmental, reproductive and systemic toxicity in various species.
Cancer may also be of concern. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife.
The petitioners conclude, based on the references provided, that all PFAS
have the potential for causing the adverse health and environmental effects linked to well-characterized substances like PFOS and PFOA
because of their common structural characteristics, and that there is a strong basis to conclude that the 54
PFAS covered by this petition may present an unreasonable risk of injury
Ref. 1, pg. 18.
2. Insufficiency of Information The petitioners assert that for these 54
PFAS, there is insufficient information and experience upon which the effects of such manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted. To support their assertion, the petitioners point to:
ATSDRs draft 2018 Toxicological Profile for Perfluoroalkyls Ref. 2, which the petitioners assert underscores the absence of toxicological data; and EPAs PFAS Action Plan Ref. 3, which states there are many PFAS of potential concern to the public that may be found in the environment. Most of these PFAS lack sufficient toxicity data to inform our understanding of the potential for adverse human or ecological effects.

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